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临床试验/NCT05611112
NCT05611112进行中(未招募)不适用

Problem-Solving Therapy for Patients With Chronic Disease and Poor Mental Well-being in General Practice

University of Aarhus2 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
188
试验地点
2
主要终点
Mental health - Depression

研究概览

简要总结

In Denmark the vast majority of patients with chronic ischemic heart disease and/or type 2 diabetes are managed in general practice. 20% of the patients suffer from poor mental health.

Problem-solving therapy (PST) is a psychotherapeutic method that is proven effective in adults with poor mental health. PST can be provided in general practice.

The main objective of this study is to test effectiveness of providing PST to this group patients.

详细描述

20% of patients with type 2 diabetes and/or chronic ischemic heart disease have poor mental health. Since these patients are managed in general practice interventions targeting poor mental health in these patients should be delivered in here.

Problem-solving therapy (PST) is a well-established psychotherapeutic method that can be delivered by health care providers in general practice.

The main objective of this study is to test the effectiveness of delivering PST for patients with T2D and/or IHS who suffer from poor mental health. We hypothesize that the patients' mental health will be improved after treatment with PST.

Health care providers from 12 general practices are trained in PST and subsequently provide PST for patients with T2D and/or IHS and poor mental health.

Patients are recruited at the annual control visit for the chronic disease. All patients are screened for impaired mental health with the WHO-5 questionnaire. Patients with a score below 50 are offered PST.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • +18 years
  • Diagnosed with ischemic heart disease and/or type 2 diabetes
  • Poor mental health defined as WHO-5 well-being index <50 points

排除标准

  • severe mental illness including psychotic disease and suicidal behaviour
  • unable to read and understand Danish

结局指标

主要结局

Mental health - Depression

时间窗: 12 months

Patient Health Questionnaire-9 (PHQ-9) at 12 months of follow-up

次要结局

  • Mental health - Anxiety(6 months)
  • Lipid profile(Baseline and 12 months)
  • Blood pressure(Baseline and 12 months)
  • Medication adherence(Baseline and 12 months)
  • Diabetes related stress(12 months)
  • Mental health - Depression(6 months)
  • Prescriptions of psychopharmacological medications(12 months)
  • Health literacy(Baseline)
  • Use of health care services(Baseline and 12 months)
  • Smoking status(Baseline and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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